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| Other Laboratory Operations Food and Drug Administration |
| DOCUMENT NO.: III-07 | VERSION NO.:1.3 | Section 7 – Private Laboratory Guidance | EFFECTIVE DATE: 10/01/2003 | REVISED: 06/27/2008 |
7.2 Sampling
Sampling for analysis is to represent the lot. If, in the judgment of
the reviewing office, the method of collection does not result in a representative
sample, the analytical package should be rejected. Sampling should be
performed in conformance with FDA-recommended sampling procedures and Compliance
Programs. (www.fda.gov/ora/cpgm and
Investigations Operations Manual, Ch. 4 www.fda.gov/ora/inspect_ref/iom/iomtc.html )
The sampler properly collects, identifies, and maintains samples from the time
they are collected until they are delivered to the private laboratory. The
sampler should:
- verify the location and identity of the lot to be sampled;
- collect samples following FDA sampling guidelines or other
equivalent, established guidelines;
- ensure the integrity of the sample (avoid contamination, maintain
sterility or storage temperature, and take other measures as needed to protect
the integrity of the sample);
- identify the containers from which samples are collected with the
FDA sample number or the U.S. Customs Service entry number;
- prepare and ship the sample using precaution to prevent contamination
and maintain sample integrity; and
- complete a collection report for each sample collected that documents
sample collection methods, sample preparation techniques, lot size and
identification number, sample size, identity of the sample collector, statement
from the collector of any observations about the lot, containers, etc., and
description of chain of custody of the sample.
If the method of collection does not result in a representative sample, the
analytical package is considered unacceptable.
Attachment 1 is a suggested form for a collection report.
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